FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150121–150144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1984
OSTEOGEN
K843398 · LYC
Impladent
Dental · 120d
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706 · DTB
Medtronic Vascular
Cardiovascular · 97d
Cleared Dec 27, 1984
MEADOX SURGIMED A/S CATHETER SHEATH SYS
K843798 · DYB
Meadox Surgimed, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802 · DTW
Shiley, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
ERGO-OXYSCREEN
K843841 · BZG
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Dec 27, 1984
OXYSCREEN
K843860 · BZC
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Dec 27, 1984
MYOCARDIAL INSULATOR
K843983 · DTR
Norton Texas Medical Products
Cardiovascular · 77d
Cleared Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · LDF
Electro-Catheter Corp.
Cardiovascular · 76d
Cleared Dec 27, 1984
MENSTRUAL PADS
K844035 · HHD
American Disposable Products Corp.
Obstetrics & Gynecology · 72d
Cleared Dec 27, 1984
CANMED 102
K844099 · DRX
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
CANMED 101
K844100 · DRX
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN
K844137 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
K844138 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY INTRACARDIAC SUCKERS
K844139 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
K844140 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
NELLCOR PULSE OXIMETER N-10
K844256 · DQA
Nellcor, Inc.
Anesthesiology · 55d
Cleared Dec 27, 1984
NEWPORT VENTILATOR MODEL E-100
K844350 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 48d
Cleared Dec 27, 1984
SECURIPIN
K844457 · EBL
Hughes Int'L, Inc.
Dental · 41d
Cleared Dec 27, 1984
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · HQC
Chiron Vision Corp.
Ophthalmic · 27d
Cleared Dec 27, 1984
THE GENERIC OXYGEN CONCENTRATOR
K844852 · CAW
Proto-Med, Inc.
Anesthesiology · 14d
Cleared Dec 24, 1984
VIBRAMETER
K843486 · LLN
Somedic AB
Neurology · 109d
Cleared Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · CAW
Everest & Jennings, Inc.
Anesthesiology · 53d